CLI Treatment Using Long and Scoring Balloons

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1 CLI Treatment Using Long and Scoring Balloons Robert Beasley, MD Director of Vascular and Interven3onal Radiology Mount Sinai Medical Center Miami Beach, FL

2 Disclosures Consultant/Advisory Board: Abbott Bard BSCI Cordis Cook CSI Endologix Gore Lombard Medtonic/Covidien Penumbra Spectranetics

3 Critical Limb Ischemia (CLI) Significant obstruction of the arteries which seriously decreases blood flow to the extremities and has progressed to the point of rest pain, poor wound healing, and/or ischemic tissue (gangrene).

4 Critical Limb Ischemia CLI is often the result of long SFA and/or long infrapopliteal stenoses or occlusions therefore longer balloons and stents are being developed. Long balloons, up to 30 cm in length are now available Developments in crossing technology make intervention a possibility in almost all PAD patients. G70072 Rev.1 4

5 CLI and Angioplasty G. Dorros, M.R. Jaff, et al. CIRCULATION 104: , 2001 The TPVA procedural and follow- up results were superior to those of the historical surgical series; the differences in endovascular and surgical survival rates, however, are even more drama>c when the surgical procedural opera>ve mortality is considered. Endovascular procedures offer a significant alterna>ve to surgical procedures.

6 CLI and Angioplasty Dorros et al. N=284 CLI 95% success Relief of rest pain and/ or improved distal blood flow Patients were followed for 5 years

7 Angioplasty Mechanism Plaque Fracture Stretching of Vessel Wall Lumen Expansion T. B. Kinney, A. K. Chin, G. W. Rurik, J. C. Finn, P. M. Schoor, W. G. Hayden and T. J. Fogarty, RADIOLOGY 153(1):85-89, 1984 W.R. Casteneda-Zuniga, R. Sibley and K. Amplatz, ANGIOLOGY 35(4): , 1984 N. L. Mills and R. J. Solar, Coronary Artery Balloon-Catheter Dilatation Intraoperatively in Current Surgery of the Heart, A. J. Roberts and C. R. Conti, Eds., J. B. Lippincott Co., 1987

8 Why optimize balloon angioplasty? Balloon angioplasty plays a critical role in almost all cases as either the definitive therapy, as preparation for stenting, to further dilate post atherectomy, or to deliver drugs Drug Eluding Balloons Scoring Balloons AngioSculpt Plaque-Modifying Balloons Chocolate Focal Force Balloons VASCUTRAK PTA Dilatation Catheter

9 Clinical Challenges Complex lesions Small BTK vessels / long diffuse disease Resistant and highly calcified lesions High pressure dilatations May increase arterial trauma May produce major dissections Plaque shift in bifurcations Higher restenosis rates

10 Theoretical Advantages of Long Balloons Decreased procedural time Decreased radiation exposure Less vessel occlusion time and risk of thrombosis Less risk of emboli resulting from advancing or withdrawing winged balloons across diseased segments Less risk of dissection as dilation is from normal segment distally to normal segment proximally

11 VASCUTRAK PTA Dilatation Catheter

12 VASCUTRAK Catheter Variety of balloon sizes: Diameters 2.0 to 7.0 mm Lengths 20 to 300mm

13 VASCUTRAK Catheter 65 y.o. Male Calcified CTO popliteal VASCUTRAK Catheter 6 mm x 200 mm 10 ATM x 2 minutes Courtesy of Dr. David Cohen Valley Hospital, Ridgewood, NJ

14 AngioScore AngioSculpt PTA Scoring Balloon Catheter Indications for Use: Dilation of lesions in the iliac, iliofemoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions.

15 European Registry for Infra-Popliteal Disease Scheinert D, Peeters P, Boisers M et al. Results of the multicenter firstinman study of a novel scoring balloon catheter for the treatment of infrapopliteal peripheral arterial disease. Catheter Cardiovasc Interv. 2007;70: Results: 42 Patients, 52 Lesions Treated Ages years, 59.5% male CLI (Rutherford 4) present in 38 patients (90.5%) Moderate/severe calcium present in 73% of lesions Lesion length: 33.9mm (range: 5-200mm) AngioSculpt successfully deployed in 55/56 lesions (98.2%) AngioSculpt used as primary therapy in 50/56 lesions (89.3%)

16 Angiographic Results

17 Limb Salvage Rate

18 Primary Patency Rate

19 AngioScore Stand-Alone Treatment on PT Scheduled for Amputation

20 AngioScore

21 AngioScore

22 CHOCOLATE PTA Balloon Catheter Flow Limiting Dissection is a Challenge With conventional balloons, inflation can result in vessel trauma which often leads to dissection. There are three primary reasons this occurs: 1. Torsional Stress (Twisting) 2. Radial Stress (Expanding) 3. Longitudinal Stress (Elongating)

23 The CHOCOLATE BAR Study (n=354) Population Characteristics 1 ATK N=180 BTK N=174 Patient Populations Calcification Lesion Length Average Age Male 63.9% 66.7% Diabetes 54.4% 54.0% CLI 24.6% 53.8% Rutherford % 28.9% Rutherford 6 0% 4.6% CTO 16.1% 30.5% Severe 34.6% 31.6% Moderate 29.6% 29.9% Mild 27.4% 27.0% None 8.4% 11.5% Average 93.2 mm 88.5 mm Range 10 mm 380 mm 5 mm 380 mm

24 The CHOCOLATE BAR Study (n=354)

25 CHOCOLATE Advantages No-Stent Zones CFA Popliteal Tibials Would not recommend if committed to stenting lesion Provides greater precision on contact and relieves plaque pressure, drastically reducing flow limiting dissections. Atherectomy + Chocolate

26 Atherectomy + Chocolate 57 y/o F with history of PVD, HLP, polymyalgia rheumatica Pre- Atherectomy Post- Atherectomy, Pre- Chocolate Post- Chocolate

27 The Future of Angioplasty Future is promising: Addition of antiproliferative drugs on long balloons, both ATK and BTK Iterations with scoring balloons and plaque modifying balloons are extremely exciting

28 Thank You